RT Journal
A1 Tuttle DA, Sasich LD, Sukkari SR
T1 IMproving access to fda reviews and documents
JF JAMA
JO JAMA
YR 2009
FD November 25
VO 302
IS 20
SP 2204
OP 2205
DO 10.1001/jama.2009.1726
UL http://dx.doi.org/10.1001/jama.2009.1726
AB
To the Editor: The Commentary by Dr O’Connor1 highlighted the importance of using publicly available US Food and Drug Administration (FDA) review documents in conducting independent assessments of the therapeutic value of new drugs. Many trials submitted to the FDA were recently found to be unpublished 5 years after new drug approvals.2 Accordingly, the information that is easily available in the published medical literature is incomplete and potentially biased.